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The new PCSK9 inhibitors -- with an annual cost of over $14,000 a year -- are far too expensive to be broadly used in eligible populations without restrictions, according to a from the Institute for Clinical and Economic Review (ICER). The price of the new drugs would need to fall to nearly $2,000 in order for the drugs to be used without limitations.
"Even if these drugs were used in just over 25% of eligible patients, then employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs, a cost that would continue on into the future," said Steven Pearson, MD, the Founder and President of ICER, in
"Our draft report therefore suggests that $2,177 is the price that should serve as an alarm bell -- if the cost is more than $2,177 a year, drug companies, doctors, insurers, and other parties may need to work together to determine ways to limit the use of these drugs, find savings in other parts of the health care system, or adopt other measures to help make these drugs more affordable," Pearson continued.
A revised version of the report will serve as the basis for a discussion and a vote on October 27 at the next meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC).
The report found no significant differences between the two newly approved PCSK9 inhibitors, alirocumab (Praluent, Regeneron and Sanofi) and evolocumab (Repatha, Amgen). A detailed review of the literature found that the drugs reduce LDL cholesterol in patients by about 55-60%. From the available data prior to the completion in 2017 of the large cardiovascular outcomes trials the report concludes with "moderate certainty" that the LDL lowering effect of the drugs "will translate into lower rates of heart attack and stroke."
Compared to statin therapy alone, the report calculates that 28 patients with familial hypercholesterolemia (FH) would need to be treated with a PCSK9 inhibitor for 5 years to prevent one major adverse cardiovascular event. This works out to a cost of $681,000 for each additional quality-adjusted life year (QALY) gained.
By comparison, adding ezetimibe to a statin resulted in a NNT of 94 and a cost of $373,000 for each additional QALY gained. For secondary prevention in statin-intolerant patients the numbers are not as high but the cost for each additional QALY was still over half a million dollars for the PCSK9 inhibitors.